MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-20-25-8-E

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign body, removal of (2365)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The stent has been released, but the safety wire was not removed.That was the reason why the stent did not detach from the carrier system.The customer has been re-trained on the use of the device.Additional info confirmed that the stent could not deployed successfully in the pt.The stent and the delivery system were removed from the pt.A section of the device did not remain inside the pt's body.The pt did not require any additional procedures due to this occurrence.The pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This complaint is reportable on the basis of the reporting precedence established for this product family for 'deployment issue resulting in exposed stent being removed from pt with the delivery system' regardless of the pt outcome.It was confirmed that this incident was a result of user error as the safety wire was not removed from the device in order for the stent to be released from the introducer.There was no malfunction of the device noted based on the evaluation of the returned device.A 1 x evo-20-25-8-e device of lot #c1100742 was returned for evaluation.On evaluation of the returned device, ti was observed that the safety wire was returned within the device.The safety wire was still connected the stent to the introducer.The red marker on top of the introducer was on the last notch; passed the point-of-no-return.The cirl research and development engineer commented that this issue would be user error as the safety wire would need to be removed in order for the stent to be released from the introducer.There was no malfunction of the device noted.It may then be noted that the most likely cause for the stent not deploying was user error as per the complaint description and device evaluation.The complaint info confirmed that the customer has been re-trained in the use of the device.The customer complaint could not be confirmed as there was no malfunction of the device noted.Prior to distribution, all evo-20-25-8-e devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for lot #c1100742 revealed no discrepancies related to this complaint issue.According tot he instructions for use, that accompanies this device the user is advised of the following: "when stent point-of-no-return has been passed, pull safety wire out of delivery handle".From the info provided, there were no adverse effects to the pt due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. specialist ; 61334440
• MDR Report Key: 4894794
• MDR Text Key: 6537868
• Report Number: 3001845648-2015-00132
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2017
• Device Catalogue Number: EVO-20-25-8-E
• Device Lot Number: C1100742
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1